Director, Regulatory Affairs

Element Science•Redwood City, CA

10h

About The Position

Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery. We are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience—designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care during this critical period. Headquartered in the San Francisco Bay Area, Element Science is backed by leading healthcare and technology investors, including Third Rock Ventures, GV (Google Ventures), Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities. SUMMARY OF ROLE: We are seeking a Director, Regulatory Affairs to join our growing medical technology company. This individual will be responsible for leading regulatory strategy and submissions for our products, managing post-approval compliance obligations, and supporting quality and other cross-functional organizations on post-market surveillance and MDR reporting to meet business expectations. The ideal candidate will have excellent people skills and a can-do attitude as well as a passion for working on a cutting-edge, life-saving product.

Requirements

Science or Engineering background required (M.S. or B.S. with 10+ years of regulatory experience) in medical device with at least 5 years focused on class III PMA products.
Proven ability to represent Regulatory on project teams and at Health Authority meetings.
Demonstrated strategic thinking skills, sound judgement, and ability to integrate strategies into actionable plans.
Strong knowledge of U.S. FDA Class III device regulations, PMA lifecycle management (supplements, PCCPs, PAS), and post-approval compliance obligations under 21 CFR Parts 803, 806, and 814; working knowledge of EU MDR and international frameworks a plus.
Direct experience with AI/ML-enabled medical devices, SaMD regulatory strategy, or predetermined change control frameworks strongly preferred.
Familiarity with DME distribution models and associated regulatory considerations (Medicare/CMS coverage, HCPCS coding, supplier standards) is a plus.
A thorough understanding of the development process and working knowledge of the essential activities for all key functional areas.
Excellent oral and written communication skills; solid grasp of effective regulatory writing fundamentals and ability to communicate complex issues clearly and concisely.
Strong team player: the ability to work flexibly in a collaborative environment and assist team members as needed to achieve goals.
Capable of project managing regulatory workstreams, identifying the critical path for submissions, and partnering with functional leads to manage timeline risk.
Able to work independently on competing priorities in a fast-paced and dynamic environment, a creative thinker with good attention to detail.
Established credibility with U.S. FDA (CDRH), including experience navigating Q-Sub/Pre-Sub meetings, deficiency letter responses, and informal FDA interactions; Notified Body experience a plus.
Evidence of technical knowledge to foster scientific credibility with regulatory agencies.
Appreciation for quality systems, risk management, and medical product development.

Nice To Haves

working knowledge of EU MDR and international frameworks a plus.
Direct experience with AI/ML-enabled medical devices, SaMD regulatory strategy, or predetermined change control frameworks strongly preferred.
Familiarity with DME distribution models and associated regulatory considerations (Medicare/CMS coverage, HCPCS coding, supplier standards) is a plus.
Notified Body experience a plus.

Responsibilities

Serve as Regulatory Lead, representing the Regulatory Department on cross-functional teams.
Develop and implement US and global regulatory strategies for PMA marketed products with AI/ML, including PMA supplements, Predetermined Change Control Plan (PCCP) and 510K pathways for accessory devices.
Identify innovative, data-driven regulatory approaches, define plans to proactively mitigate risks, and monitor the competitive and policy landscape for changes with potential impact.
Lead the organization and preparation of clear and effective regulatory submissions that align with company strategies and Health Authority requirements.
Foster strong relationships with relevant regulatory agencies and key stakeholders while advocating for company positions.
Lead interactions with regulatory agencies and health authorities, interpret feedback, and ensure that the outcome is properly communicated to the Organization.
Effectively represent the Regulatory Affairs function to senior leadership at governance meetings.
Lead the organization and preparation of clear and effective regulatory submissions aligned with business strategies and regulatory requirements.
Lead preparation of PMA supplements, including but not limited to AI/ML updates, manufacturing changes, design changes in compliance with 21 CFR 814.
Manage PCCP strategy and amendment lifecycle, including Q-Sub interactions with FDA for Real Time Review and other expedited pathways
Lead regulatory submissions for clinical investigations (IDEs) and PMA Post Approval Studies (PAS), including annual reports, study modifications.
Lead and manage the preparation of technical documents and dossiers for regulatory submissions.
Ensuring ongoing compliance with regulatory requirements and managing up-to-date regulatory submission and correspondence files.
Maintain Technical Files to meet state-of-the-art requirements; support EU MDR post-market documentation (CER, PMCF, SSCP) in coordination with Notified Body and external partners as applicable.
Partner with engineering and commercial teams to assess software and digital health features against FDA software as a Medical Device (SaMD) and MDDS frameworks, determining applicable regulatory pathways.
Evaluate labeling, promotional materials, and clinician-facing portals for regulatory compliance.
Support the organization with MDR reportability determinations in coordination with Quality.
Create a strong regulatory culture and share best practices across the broader organization.